Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars.
The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
Theravance (THRX): On 4/24/09, the FDA accepted as complete for review Theravance’s response to the February 2009 Complete Response Letter (CRL), which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). Telavancin is a novel, bactericidal, once-daily injectable investigational antibiotic studied in the treatment of cSSSI and hospital-acquired pneumonia (HAP) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The PDUFA decision date for the cSSSI indication for telavancin is 9/16/09 while the decision date for the HAP indication occurs later in the year on 11/26/09.
Johnson & Johnson (JNJ): On 4/24/09, SIMPONI (golimumab) recieved FDA approval as the first once-monthly anti-TNF treatment for three types of auto-immune arthritis conditions, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Medarex (MEDX) is set to receive royalties on the drug as part of the UltiMAb (a technology platform for the development of human monoclonal antibody treatments) licensing agreement with JNJ while Schering-Plough (SGP) holds the exclusive marketing rights to Simponi outside of the U.S. (ex-Japan, Taiwan, and Indonesia).
In mid-April, Pro Pharmacueticals Inc. (PRWP) announced that a review of Phase 1 and 2 clinical trial data revealed that about 100 patients treated with the Company’s lead compound in development called DAVANAT in combination with chemotherapy (including 5-FU regimens) experienced no incidence of mucositis serious adverse events (SAEs). Mucositis is a common side effect of many cancer treatments which can interfere with treatment and the ability to eat or drink normally. The condition causes painful inflammation, ulceration, and sores of the mucous membranes within the gastrointestinal (GI) tract.
The data also revealed that patients who received more than 100 cycles of cancer treatments with DAVANAT + 5-FU experienced no GI SAEs. 5-FU is a widely used type of chemotherapy drug that typically results in a 40% incidence of mucositis, including SAEs of grade 3-5, which can be life threatening and require hospitalization.
